An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line Treatment

Trial Information

An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line Treatment

Inclusion Criteria:

- Age ≥18 years

- Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic and
therefore not amenable to surgery or combined modality with curative intent prior to
or at Visit 1

- At least one measurable site of disease on CT/MRI scan at Visit 1, as defined by
RECIST criteria (see Post Text Suppl 3 for details) The scans should be at maximum 2
weeks old. New scans are only required as baseline scans if they are older then
approx. 2 weeks.

- WHO Performance Status of 0, 1 or 2

- Patients must have the following laboratory values (≥ LLN (lower limit of normal) or
corrected to within normal limits with supplements prior to the first dose of study
medication.):

1. Potassium ≥ LLN,

2. Magnesium ≥ LLN,

3. Phosphorus ≥ LLN,

4. Total calcium (corrected for serum albumin) ≥ LLN

- Patients must have normal organ, electrolyte, and marrow function as defined below:

1. Absolute Neutrophil Count (ANC) ≥ 1.5x 109/L;

2. Platelets ≥ 100 x 109/L;

3. ALT and AST ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if considered due
to tumor;

- Patients with severe and/or uncontrolled concurrent medical disease that in the
opinion of the investigator could cause unacceptable safety risks or compromise
compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI
disease that may significantly alter the absorption of the study drugs, uncontrolled
diabetes

Type of Study:

Interventional

Study Design:

Outcome Measure:

To evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors. Efficacy is defined as the proportion of patients showing stable disease (SD), partial response (PR) or complete response (CR) during the

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107DDE06

NCT ID:

NCT00756509

Start Date:

August 2008

Completion Date:

December 2013

Related Keywords:

Gastrointestinal Stromal Tumors

unresectable or metastatic GIST

1st. line treatment

Gastrointestinal Stromal Tumors

Name

Location

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